BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer

NCT04891068 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2021-0215
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer, paired t-tests will be first used to compare TIL count in pre- and post-treatment specimens.

Conditions

Breast Cancer Invasive; Early-stage Breast Cancer; High Risk Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in tumor infiltrating lymphocytes (TILs) count in primary tumors from patients with high-risk early stage breast cancer following low-dose azacitidine therapy.

  Number of participants that show tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer

  2 weeks from first dose of azacitidine

Secondary Outcomes (5)

• Clinical response (change Ki67 and tumor size) of primary tumor following treatment with low dose azacitidine therapy

  2 weeks from first dose of azacitidine

• Safety - completion rate of low-dose azacitidine

  30 days after last dose of azacitidine

• Safety - tolerability of low-dose azacitidine therapy assessed by using the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5

  30 days after last dose of azacitidine

• Disease Free Survival (DFS)

  2 years

• Overall Survival (OS)

  2 years

Study Arms (1)

Single arm with previously untreated high risk early stage breast cancer

EXPERIMENTAL

All participants will receive azacitidine 50mg/m2 SC daily for five consecutive days.

Drug: Azacitidine

Interventions

Azacitidine DRUG

5-Azacitidine is a pyrimidine nucleoside analog in which nitrogen replaces carbon at position 5

Also known as: Vidaza

Single arm with previously untreated high risk early stage breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years of age at time of consent
• ECOG 0, 1, or 2
• Histologically confirmed invasive breast carcinoma documented by biopsy. AJCC 8th edition clinical stage T1a-T3/N0-N1/M0 by physical exam or radiologic studies
• Disease characteristics I. TNBC (Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC). HER2-negative, as defined by ASCO/CAP guidelines)
• II. ER positive (as determined by immunohistochemistry (IHC)) and any of the following high risk characteristics:
• HER2 positive (IHC or FISH)
• Node positive
• Any clinical high-risk expression profile (mammaprint, oncotype, endopredict)
• PR negative (IHC) OR III. HER 2 positive (as defined by ASCO/ACP guidelines) f. Demonstrates adequate organ function as defined in table below. All screening labs to be obtained within 30 days prior to registration.
• System Laboratory Value Hematological Leukocytes ≥3,000/mm3 Platelet count ≥ 100,000/mm3 Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 Hemoglobin (Hgb) ≥ 9.0 g/dL Renal Creatinine/Calculated creatinine clearance (CrCl) Cr \< 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL/min using the Cockcroft-Gault formula Hepatic Bilirubin Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin \> 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN g. No evidence of distant metastases (M0 per AJCC staging guidelines) h. Provided written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
• i. Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
• j. As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

You may not qualify if:

• Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer.
• Any type of breast implants
• Active infection requiring systemic therapy
• Uncontrolled HIV/AIDS or active viral hepatitis
• Pregnant or nursing
• Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
• Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial unless a Legal Authorized Representative (LAR) is in place to sign on behalf of the patient.
• Other major comorbidity, as determined by study PI

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Vijayakrishna Krishnamurthy Gadi, MD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VK Gadi, MD, PhD

CONTACT

312-996-1581; vkgadi@uic.edu

Michelle Karan, BS

CONTACT

224-563-7137; makaran2@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Model Details: Single arm, window of opportunity trial in which patient with previously untreated high risk early stage breast cancer will receive 5 consecutive days of azacitidine 50mg/m2 SC followed by standard of care therapy

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 18, 2021
• Study Start: January 10, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)